The Recall Desk
HighFDA (Devices)·Z-0937-2022·Announced 2022-04-20

CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a device that fails to meet critical electrical safety specifications for defibrillation. No illnesses or injuries have been reported, but the hazard represents significant risk to patient safety where defibrillation may be life-critical.

Plain-English summary

Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode IP SET M5 RT ADULT-US (Model 32028778 50601-US) due to electrical safety non-compliance. The device's Instructions for Use claim compliance with the ANSI/AAMI EC53:2013/(R)2020 standard, which requires electrodes to withstand 5,000 volts direct current when used with defibrillators. However, testing found the device does not meet this specification and delivers an inefficient electrical charge, which may result in ineffective defibrillation.

The recalled product was distributed to medical facilities in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots are affected (UDI: 03700506307333). Healthcare providers and hospitals should immediately discontinue use of this electrode and contact the manufacturer for replacement units.

The recalled product

Product
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Manufacturer
Graphic Controls Acquisition Corporation
Category
Medical Device — Cardiac Electrode
Hazard
  • defibrillation-failure
  • electrical-safety
  • specification-non-compliance

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots UDI: 03700506307333

Distribution

Distributed nationwide across the United States.

Related recalls

Same category